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Clinical Trials/EUCTR2017-003638-10-FR
EUCTR2017-003638-10-FR
Active, not recruiting
Phase 1

INTRANASAL CLONIDINE PREDICTION IN PEDIATRIC SURGERY: RANDOMIZED STUDY AGAINST PLACEBO - CLONIPREM

CHRU LILLE0 sites150 target enrollmentJanuary 12, 2018

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Not specified
Sponsor
CHRU LILLE
Enrollment
150
Status
Active, not recruiting
Last Updated
8 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
January 12, 2018
End Date
TBD
Last Updated
8 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
CHRU LILLE

Eligibility Criteria

Inclusion Criteria

  • \- Age of 1 to 5 years,
  • \- Weight from 10 to 25 kg
  • \- Signature of informed consent
  • \- ASA 1 or 2, (ANNEX 6\)
  • \- Scheduled minor surgery
  • \- Affiliation to Social Security
  • Are the trial subjects under 18? yes
  • Number of subjects for this age range: 150
  • F.1\.2 Adults (18\-64 years) no
  • F.1\.2\.1 Number of subjects for this age range

Exclusion Criteria

  • \- Failure to obtain consent,
  • \- Participation in another clinical trial involving a drug,
  • \- Known contraindications or hypersensitivity to clonidine, or to any of
  • the excipients,
  • \- Upper airway infection within 3 weeks prior to inclusion,
  • \- Intravenous Induction,
  • \- History of cardiac arrhythmia, congenital heart disease,
  • \- Mental retardation or psychoactive treatment.

Outcomes

Primary Outcomes

Not specified

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